MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)
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Patient Problem
Pain (1994)
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Event Date 11/13/2023 |
Event Type
Injury
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Event Description
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2023-nov-16: information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient reported the patient was implanted 3 days ago and haven't received the relief they desired.Pt noted they needed an mri, but they were told they couldn't have an mri.Patient services specialist helped the patient enter mri mode and confirmed they were head eligible.Patient service specialist reviewed the external equipment was functioning as intended.The patient was redirected to their healthcare provider to further address the issue.2024-jan-03: additional information was received from the patient.They clarified that they were not getting adequate pain relief; the lead traveled it caused pain plus lack of relief.Patient continued stating the wrong device was installed after they told them that they need to get mri's.X-ray's were taken to show the lead traveled.The issue is not resolved, they are planning on getting a revision.
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Manufacturer Narrative
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Product id: 977a260, implanted: (b)(6) 2023, product type: lead.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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It was reported there was a return of pain due to lead migration.Revision not yet scheduled.
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Manufacturer Narrative
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Continuation of d10: product id 977a260 serial# (b)(6) implanted: (b)(6) 2023 product type lead.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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